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Ref No: KP-3612
Job Title: DIRECTOR GLOBAL PHARMACOVIGILANCE – suitable for PHYSICIAN
Description:

BACKGROUND

Chiltern is a well established privately owned full service (Phase I-IV) Clinical Research Organization, with over 1400 employees and 23 offices throughout North and South America, Europe (both Eastern and Western) and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.
 
Our medical function plays an essential role in providing the necessary framework for the successful start-up and management of clinical projects, providing input to the project teams at every stage. We are now looking for a Physician to act as a key member of the Pharmacovigilance team.
 
The Director leads the Pharmacovigilance (PVG) team at a global level by overseeing and managing the PVG Managers, serving as a Drug Safety Physician for individual projects, and overseeing PVG processes and project timelines.
 
This is a high profile role within the Pharmacovigilance department and he/she must use his/her experience as a ‘knowledge resource’ for the department and to help team members develop their skills both individually and as a team.
 
PRIMARY DUTIES
 
Management:
- To have a permanent line management team consisting of a Pharmacovigilance Operations Manager and Pharmacovigilance Managers.
- To ensure team members are complying with all requirements of their job description.
- To maintain an appropriate knowledge and understanding of their team member’s projects, project roles, and project timelines.
- To maintain ongoing responsibility for the identification and provision of training, liaising with the Training department as appropriate.
- To meet/discuss regularly, individually with direct reports to review personal well-being, allocation, working hours and progress of objectives set during appraisals.
- To oversee that PVG budgeting for projects, monthly invoices and revenue recognition are appropriately performed.
- To take measures to improve the efficiency of the department, including notification of problems, in collaboration with the Chief Medical Officer.
 
Pharmacovigilance Activities:
- To provide medical support to and/or serve as the Qualified Person for Pharmacovigilance to Marketing Authorisation Holders, as required.
- To act as Drug Safety Physician, performing and/or overseeing the following tasks, as required for specific projects: 
Requirements:

 QUALIFICATIONS

- Medical Degree.
- Extensive knowledge of Global Pharmacovigilance / Drug Safety for Clinical Trials and Marketed Products.
- UK GMC registration desireable but NOT mandatory.
- The company works across a range of therapy areas and thus is happy to consider applicants from any medical background.
- Demonstrated ability to conduct medical activities effectively, efficiently and with the minimum of supervision.
- Thorough understanding of the principles of ICH GCP and regulatory requirements.
- Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
- Excellent oral and written communication, organisational skills and personal presentation with the ability to communicate effectively in English.
 
ADDITIONAL INFORMATION
This is a full time permanent position based at out offices in Slough, Berkshire or in Edinburgh.
 
You will be primarily office-based but some work may involve travel to meetings or attendance at conferences locally or internationally (as required). Thus you must be able to travel internationally without any restrictions.  Overnight stays may be required.
 
For a confidential discussion about this opportunity, please telephone our Global Internal Recruitment Manager, Kaushik Pankhania (KP) on +44 (0)1753 216 680To apply, please send your CV to kp@chiltern.com
 
For more information about Chiltern, please visit our web site at www.chiltern.com
Salary: Competitive Salary + Car or Allowance + Flexible Benefits
Position Type: Full Time - Permanent , UK - Scotland
Contact: Kaushik Pankhania
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